NCT02791360已完成不适用
Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor
Centre Francois Baclesse2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Proportion of patient with MRI abnormality
研究概览
简要总结
Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In the case group:
- •A history of solid brain tumor or haematological histologically proven.
- •Patients previously treated with radiotherapy in this brain tumor (greater than or equal to 36 Gy dose).
- •Radiotherapy treatment on a tumor in place or operated.
- •Decline at least 10 years from the end of radiotherapy.
- •Treatment with isocentric conformal radiotherapy.
- •No other radiation therapy for locally recurrent brain metastases or new brain tumor.
- •Lack of known brain metastases or meningeal carcinomatosis.
- •For the control group:
- •Patients previously treated for cancer and disease relapse free for 10 years.
- •No brain radiotherapy treatment.
- •Lack of treatment with anti-cancer chemotherapy.
- •Women of childbearing potential must be under effective contraception.
- •Pairing according to age, sex, arms director and socio-cultural level.
- •For two groups:
- •Man or woman aged (e) of minimum 18 years.
- •Topic fluent French and comprising well.
- •Free and Informed Consent signed.
- •The subject should be affiliated to an appropriate social security system
- •No cons-indication to MRI.
- •The subject must have at least one primary school level
排除标准
- •In the case group:
- •Brain radiotherapy carried out by intensity modulation technique.
- •Radiation dose less than 36 Gy on the brain.
- •Subject with against-indication to MRI.
- •For the control group:
- •Previous history of brain radiotherapy.
- •Previous history of brain surgery.
- •Central neurological disorders, such as seizures, uncontrolled.
- •For two groups:
- •Current Topics in oral chemotherapy or intravenous.
- •Subject pregnant.
- •Subject is not fluent in French or including bad.
- •Any geographical conditions, social or associated psychopathology that could compromise the patient's ability to participate in the study.
- •Participation in a therapeutic trial for less than 30 days.
- •A person not affiliated with a social security scheme.
研究组 & 干预措施
MRI evaluation
Other
Patient pretreated for brain tumor and witness
干预措施: Brain MRI (Other)
结局指标
主要结局
Proportion of patient with MRI abnormality
时间窗: up to 4 weeks
To evaluate the proportion of patients with at least one abnormality on an imaging test
次要结局
- MRI diffusion abnormality(up to 4 weeks)
- MRI perfusion abnormality(up to 4 weeks)
- MRI vascular morphologic abnormalities(up to 4 weeks)
研究者
研究点 (2)
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